RE-SCREEN: Optimized Rehabilitation Following Primary Breast Cancer Surgery
Study Details
Study Description
Brief Summary
This study aims to evaluate the effects of an intervention based on systematic screening of psychological distress as the basis for individualised support and rehabilitation following primary breast cancer surgery focusing on psychological , physical and health-economics outcomes. The aim is also to illuminate patients' and relatives' experiences and need of support during the rehabilitation .
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Breast cancer survivors are known to suffer from remaining problems from their treatment after surgery. Despite numerous of studies evaluating the effect of various rehabilitation programs it is know that patients often receive rehabilitation recommendations that are general rather than individualised to their needs. The large amount of studies within this area have contributed to knowledge about potential beneficial rehabilitation interventions for these patients but there is still a lack of knowledge about how patients specific needs of rehabilitation can be identified and how health care can adjust and individualize rehabilitation to optimize rehabilitation. This study aims to evaluate the effects of an intervention based on systematic screening of psychological distress as the basis for individualised support and rehabilitation following primary breast cancer surgery focusing on psychological , physical and health-economics outcomes. The aim is also to illuminate patients' and relatives' experiences and need of support during the rehabilitation.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Control (high distress) Control group receiving care as usual |
Other: Care as usual
Patients will get care as usual
|
| Experimental: Individualised rehabilitation Patients with high distress receive the intervention "individualized rehabilitation" including evaluation of individual needs and based on that physical, psychological or social interventions to promote rehabilitation. |
Other: Individualised rehabilitation
Patients will get access/support to individualised rehabilitation based on their needs identified through the distress thermometer
|
| Experimental: Control group (low distress) Control group receiving care as usual |
Other: Care as usual
Patients will get care as usual
|
Outcome Measures
Primary Outcome Measures
- Psychological Distress [Instrument will be answered approximately 1 week pre-operative and after surgery at 2 weeks, 3 ,6 ,9 and 12 months postoperative. Evaluating change over time.]
Psychological Distress measured by the "Distress thermometer". A instrument that the patients answer themselves measuring the level of distress and the potential problems the may have.
Secondary Outcome Measures
- General Quality of life [Instrument will be answered approximately 1 week pre-operative and after surgery at 2 weeks, 3 ,6 ,9 and 12 months postoperative. Evaluating change over time.]
The instrument QLQ-C30 is developed by the EORTC (European Organization for Research and Treatment of Cancer) and measurers quality of life
- Information needs [Instrument will be answered approximately 1 week pre-operative and after surgery at 2 weeks, 3 ,6 ,9 and 12 months postoperative. Evaluating change over time.]
The INFO35 instrument is developed by the EORTC and measures the patients perception of information received
- Hospital Anxiety depression scale [Instrument will be answered approximately 1 week pre-operative and after surgery at 2 weeks, 3 ,6 ,9 and 12 months postoperative. Evaluating change over time.]
HADS anxiety and depression scale will be used to measure the patients level of anxiety and depression. Measured with 14 question ranging from 0-3. Higher score indicates more problems.
- Resilience [Instrument will be answered approximately 1 week pre-operative and after surgery at 2 weeks, 3 ,6 ,9 and 12 months postoperative. Evaluating change over time.]
Conner-Davidsson Resilience scale (CD-RISC) will be used to measure patients resilience trough 25 questions ranging from 0-4. Lower scores indicates more problems
- Life style changes [Instrument will be answered approximately 1 week pre-operative and after surgery at 2 weeks, 3 ,6 ,9 and 12 months postoperative. Evaluating change over time.]
Life style changes will be measured by single items concerning exercise (amount hours of physical activity/day), Body mass index (based on weight and length), alcohol (units/glasses/ day) and tobacco habits (yes/no)
- Health economics [Evaluations will be conducted after data collection is finished. 6 months and one year after inclusion.]
Cost-effectiveness analysis will be performed by evaluations of health care consumption (number of and total cost of health care visits) and by evaluating sickness absence (number of days)
- Breast cancer specific quality of life [Instrument will be answered approximately 1 week pre-operative and after surgery at 2 weeks, 3 ,6 ,9 and 12 months postoperative. Evaluating change over time.]
The instrument QLQ-BR23 is developed by the EORTC (European Organization for Research and Treatment of Cancer) and measurers diagnose specific quality of life
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Undergone treatment for primary breast cancer
-
≤18 years old
-
Ability to communicate in Swedish
-
Written informed consent
Exclusion Criteria:
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Recurrent disease
-
Palliative diagnosis
-
Pregnancy
-
Prior history of breast cancer
-
Inability to participate in the study due to cognitive impairment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Skåne university hospital | Malmö | Sweden |
Sponsors and Collaborators
- Lund University
Investigators
- Principal Investigator: Marlene Malmström, PhD, Lund university, department of health siences, Lund
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RESCREEN